Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03954158
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.
* Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month
* Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area
* Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.
Exclusion Criteria:
* Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants had previous treatment with any topical or systemic PDE-4 inhibitor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT03954158
Study Brief:
Protocol Section:
NCT03954158